N/A
N=467
HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT01315353 ↗Enrolled (actual)
467
Serious AEs
2.6%
Results posted
May 2018
Primary outcome: Primary: Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 — 24.9; 26.5 Events per 100 persons
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cervical Cryotherapy (Procedure); Loop Electrosurgical Excision Procedure (LEEP) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 |
24.9; 26.5 | — |
| SECONDARY Time to CIN2+ Diagnosis by Biopsy, as Determined by Local Review at a DAIDS-assessed Laboratory. |
31; 30 | 0.94 |
| SECONDARY Cumulative Rate of CIN3+ (CIN3 or Invasive Cancer) by Week 130. |
12.7; 17.1 | — |
| SECONDARY Number of Participants Who Discontinued Study Early. |
29; 23 | 0.445 |
| SECONDARY Number of Participants With Abnormal Cytology Results at Study Visits. |
80; 75; 80; 72; 63; 64 | 1.000 |
| SECONDARY Number of Participants With High Risk (hr)-HPV by the Abbott Real Time High-risk HPV Assay (aHPV) at Study Visits. |
74; 78 | 0.132 |
| SECONDARY Number of Participants With High Risk (hr)-HPV by the Xpert HPV Assay at Study Visits. |
64; 68 | 0.227 |
| SECONDARY Number of Participants With High Risk (hr)-HPV by the Roche Linear Array HPV Genotyping Test at Study Visits. |
74; 73 | 1.000 |
| SECONDARY Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A. |
20; 15; 13; 5; 4; 3 | — |
| SECONDARY Percentage of Participants With Targeted AEs Reported Post LEEP. |
50; 21; 22; 12; 15; 31 | — |
Summary
Women sometimes develop cancer in an area called the cervix, which is the opening to the uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who do not have HIV. Nearly all of these cancers are caused by another virus, called human papilloma virus (or HPV). Other times, the cause of this cancer is not known.
The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to prevent cancer of the cervix in women who have HIV. This study will also see if these methods are safe and tolerable in women who have HIV.
Eligibility Criteria
Inclusion Criteria
- HIV-1 infection.
- Certain laboratory values obtained within 45 days prior to study entry (more information can be found in the protocol).
- For candidates suitable for cervical cryotherapy, hr-HPV detected by aHPV within 45 days prior to study entry.
- For women without hr-HPV detected by the aHPV assay, presence of lesions on visual inspection or HSIL cervical cytology. These participants are not eligible for randomization to Arms A or B and were followed in Arm C.
- Suitable candidate for cervical cryotherapy (as defined in the protocol): No visible cervical lesions, OR (a) any visible lesions were located entirely on the ectocervix and were no more than 2 to 3 mm. into the endocervical canal, AND (b) visible lesions covered less than 75% of the cervix, AND (c) all visible lesions were deemed appropriate for cryotherapy by the treating local health care provider.
NOTE: Participants with cervical lesions inappropriate for cryotherapy are not eligible for randomization to Arms A or B and were followed in Arm C.
- For participants of reproductive potential, negative pregnancy test within 48 hours prior to study entry.
- Must agree not to participate in a conception process (e.g. active attempt to get pregnant or in vitro fertilization), or use at least one reliable contraceptive if participating in sexual activity, from time of study entry until 12 weeks after study entry.
- If recently gave birth, must be at least 12 weeks postpartum.
- Ability and willingness of participant or legal guardian/representative to provide written informed consent.
Exclusion Criteria
- Current or prior history of cervical, vaginal, or vulvar cancer.
- Prior cervical cryotherapy, LEEP, cervical conization, or total or partial hysterectomy.
- Cervical, vaginal, or vulvar lesions that are suspicious on clinical exam for cancer.
- Visual evidence of bacterial STIs (sexually transmitted infections) or suspicion of pelvic inflammatory disease.
- Prior vaccination with an HPV vaccine.
- Hemophilia.
- Currently on anticoagulation therapy other than acetylsalicylic acid.
- Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to study entry.
- Active drug or alcohol use or dependence or any other condition that, in the opinion of the site investigator, would interfere with the participant's ability to adhere to study requirements.
Data sourced from ClinicalTrials.gov (NCT01315353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.